Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV

Sponsor

Xu Siqi (Other)

Overall Status

Completed

CT.gov ID

NCT03788018

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.

METHODS: One hundred and twenty women with elective laparoscopic hysterectomy were randomly divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON group, n=60) received the equal volume of saline. Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.

Condition or Disease	Intervention/Treatment	Phase
Lidocaine Dexmedetomidine Nausea and Vomiting, Postoperative	Drug: lidocaine and dexmedetomidine IV Drug: saline IV	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Nov 15, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Effect of IV lidocaine and dexmedetomidine on PONV	Drug: lidocaine and dexmedetomidine IV Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively. Drug: saline IV Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery
Experimental: Effect of IV saline on PONV	Drug: lidocaine and dexmedetomidine IV Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively. Drug: saline IV Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery

Arm

Intervention/Treatment

Experimental: Effect of IV lidocaine and dexmedetomidine on PONV

Drug: lidocaine and dexmedetomidine IV

Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.

Drug: saline IV

Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery

Experimental: Effect of IV saline on PONV

Drug: lidocaine and dexmedetomidine IV

Drug: saline IV

Outcome Measures

Primary Outcome Measures

postoperative nausea [0-2 hours after surgery]
Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
postoperative nausea [2-24 hours after surgery]
Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
postoperative nausea [24-48 hours after surgery]
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting [0-2 hours after surgery]
Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
postoperative vomiting [2-24 hours after surgery]
Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
postoperative vomiting [24-48 hours after surgery]
Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
postoperative nausea and vomiting (PONV) [0-2 hours after surgery]
Our primary outcome was the incidence of PONV during the 0-2 hours after surgery
postoperative nausea and vomiting (PONV) [2-24 hours after surgery]
Our primary outcome was the incidence of PONV during the 2-24 hours after surgery
postoperative nausea and vomiting (PONV) [24-48 hours after surgery]
Our primary outcome was the incidence of PONV during the 24-48 hours after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
Aged 40-55 years
Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

History of allergy to local anesthetics
Severe respiratory disease
Renal or hepatic insufficiency
History of preoperative opioids medication and psychiatric
preoperative bradycardia
preoperative atrioventricular block
Subjects who experienced severe hypotension (mean arterial pressure [MAP] <60 mmHg) or bradycardia (heart rate [HR] <40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period